Latest News Stories from IMDMC

June 28, 2022

CAI’s Kneat Gx System Qualified & Released for Use


INDIANAPOLIS — CAI, a global consulting company that provides technical, operational consulting, and project management services to life sciences, data centers, and industrial process manufacturing industries, today confirmed its status as an official Kneat Platform Partner with the launch of its own validated Kneat Gx software instance following the initial development of a strategic partnership with Kneat Solutions in early 2022.

The Kneat Gx instance, a 21 CFR Part 11 and Annex 11 electronic records and signatures compliant SaaS validation solution, enables CAI to host work product on behalf of its clients, including reviews, approvals, and execution of protocols.

The CAI instance of Kneat Gx will provide a mechanism for Knowledge Management that is married directly to work product, by enabling tools and templates to be stored and managed in the same platform and format, where they can and should be used.

“Our Kneat Gx environment gives us the ability to serve our clients more efficiently, using industry best in class standardized off-the-shelf content while removing the geographic obstacles to collaboration within our global network of industry professionals,” states Mike Martin, CEO of CAI. He continues, “I am excited for what the future holds!”

“CAI continues to demonstrate their commitment to enhancing their client experience and results through the adoption of digital validation and through their partnership with Kneat,” commented Rick Mineo, Director of Strategic Partnerships at Kneat. “We are very pleased to partner with CAI, and we look forward to continuing to scale our solutions”

About CAI:
Since CAI’s founding in 1996, we have delivered nearly a billion dollars in services for hundreds of clients across thousands of projects globally. With offices in the US, Canada, Australia, Netherlands, Korea, Switzerland, India, Ireland, Italy, China, Singapore, United Kingdom, and Malaysia, we have built an international team of over 850 professionals providing local support from a global company. Our engineering, technical, and consulting services deliver mission critical facilities with a high level of performance and reliability. When operational readiness is critical, CAI delivers to a higher standard.

About Kneat:
Kneat, a Canadian company with operational headquarters in Limerick, Ireland, develops and markets the next generation Kneat Gx SaaS platform. Multiple business work processes can be configured on the platform from equipment to computer system validation, through to quality document management. Kneat’s software allows users to author, review, approve, execute testing online, manage any exceptions, and post approve final deliverables in a controlled FDA 21 CFR Part 11/ Eudralex Annex 11 compliant platform. Macro and micro report dashboards enable powerful oversight into all systems, projects and processes globally. Customer case studies are reporting productivity improvements in excess of 100% and a higher data integrity and compliance standard. For more information visit

Media Contact:
David Shenberger
[email protected]

July 21, 2021

TOMZ Corporation to Open Second Manufacturing Facility in Knightstown

TOMZ Corporation

KNIGHTSTOWN – TOMZ Corporation, a manufacturer of implantable medical devices based in Connecticut, will celebrate the opening of its second manufacturing facility in Knightstown, Indiana on Friday, August 13th. The state-of-the-art 60,000 sq. ft. facility is located near Warsaw, Indiana, also known as the “Orthopedic Capitol of the World,” allowing TOMZ to join many of its peers in orthopedics, while the accompanying 18-acre parcel allows for tremendous growth opportunity.

TOMZ Corporation’s experience in the field of medical device manufacturing spans more than three decades, with millions of medical devices in use today. TOMZ has consolidated manufacturing processes at its 150,000 sq. ft. headquarters in Berlin, Connecticut to offer shorter lead times, faster delivery, and excellent quality control. After 8 expansions of the Berlin facility, with the most recent completed in the summer of 2020, the Indiana facility will reinforce and greatly increase capacity.

With this second facility, TOMZ Corporation is looking forward to bringing a wider product range, increased volume, and additional capabilities as an instrumental partner of top medical OEMs in the medical device space.

Needless to say, there are many employment opportunities available. For mor information on TOMZ please visit their website:

TOMZ Corporation is a top-tier manufacturer of implantable medical devices for the world’s leading medical OEMs, headquartered in Berlin, Connecticut. The core of their business is medical device implants, their assemblies, and accompanying surgical instruments.

January 8, 2021

CAI Announces New Leadership Team


INDIANAPOLIS – Mike Martin assumed the role as President of CAI on 1 November 2020 and will succeed Bob Chew as CEO on 1 January 2022.  Reporting to Mike Martin as of 1 January 2021 are:

  • Rich Tree – Chief Operating Officer
  • Alice Redmond – Chief Strategy Officer
  • Phil Pursifull – Chief Financial Officer
  • Jackie Karceski – Chief Technology Officer
  • Tim Howard – Chief Human Resources Officer

Robert Chew, CEO:

“CAI has delivered on our promise to meet a higher standard for our clients the past 25 years. This year clients have called on us to help them respond to the most urgent global health crisis in the past 100 years.  I am proud of the work our team is doing and am as confident as ever that under Mike’s leadership CAI will continue thrive and earn each client’s trust every day.

Our team will be driving more value for our clients by focusing on:

  • Delivering projects faster, with higher quality, and reduced costs while solving problems for our clients. 
  • Strategic focus for growth in new geographies and service / product offerings to meet the future needs of the industries we serve. 
  • World-class accounting for accuracy and integrity.
  • Digital transformation to enhance the value of our people and teams.
  • Hiring, developing, and retaining the best talent to provide the high performing teams and technical experts our clients need.”

Mike Martin, President:

“I am excited about leading CAI and look forward to working with the leadership team to drive our business in areas critical to our mission while serving our global clients.  We are investing heavily in IT systems and applications to drive efficiency throughout our organization and expand our technology enabled services.  Likewise, we continue our geographic expansion to better serve our global clients, delivering operational readiness and operational excellence solutions all around the world.”


Since CAI was founded in 1996, we have delivered nearly a billion dollars in services for hundreds of clients across thousands of projects globally. With offices in the US, Canada, Australia, Netherlands, Korea, Switzerland, Ireland, Italy, China, Singapore, and Malaysia, we have built an international team of over 600 professionals providing local support from a global company. Our engineering, technical, and consulting services are fashioned to deliver mission critical facilities with a high level of performance and reliability. When operational readiness and startup are critical, CAI delivers to a higher standard.

June 8, 2020

Indiana Again Among ‘Best States for Business’

Inside INdiana Business

INDIANAPOLIS – Chief Executive magazine’s annual “Best & Worst States for Business” survey has once again found Indiana is primed for business. For the fifth consectuvie year, the publication ranks Indiana fifth, noting a diversifying economy with a focus on innovation and technology.

The survey conducted to calculate the rankings found manufacturing is still king in Indiana, but listed ActiveCampaigneHealth and Zotec as new operations established in the state.

It also highlighted the Next Level Connections Program and its $1 billion in infrastructure, as well as Innovative Indiana Plan, the Road to One Million Plan in northeast Indiana and Indiana’s Great Southwest plan. 

It’s the 16th year of the survey, and Texas finished first for the 16th time. After Texas, the list has Florida, Nevada, Tennessee and Indiana rounding out the top five. North Carolina dropped two spots to No. 6, while Nevada gained three spots to move to No. 3.

The survey found about 52% of site-selection projects were paused across the nation by the pandemic.

“Like the stock market, a lot of site-selection projects are built on speculation, on confidence in how things will look one or two years down the road,” says Brian Corde, co-founder of Atlas Insight. “If confidence isn’t high, it slows the pace.”

The bottom five of the survey did not change from 2019, with Connecticut, New Jersey, Illinois, New York and California bringing up the rear. Click here for a full breakdown of the survey and click here for the full list of rankings. 

May 29, 2020

Hoosier Startup Details Growth Plans

Inside Indiana Business

CARMEL – A life sciences startup has announced plans to grow its central Indiana operations. The Indiana Economic Development Corp. says Carmel-based 3Oe Scientific LLC will invest $500,000 to accelerate the growth of its patented hand sanitizing system technology and create up to 30 jobs by the end of 2022.

3Oe says its aqueous ozone hand sanitizing device infuses ozone molecules into water, which kills pathogens such as viruses, bacteria and spores naturally without soaps or chemicals. The company says users place their hands into the device for a few seconds allowing all surface areas of the hands to be covered with a steady stream of aqueous ozone.

“The technology is expected to revolutionize the healthcare and public health sectors in areas of efficacy, compliance and tracking,” said Dr. Tom Foust, founder and chief executive officer of 3Oe. “As an innovation-centric tech company, we look forward to not only positively impacting our community with our products but also growing our workforce here in Indiana as we expand and scale.”

The IEDC says the company has partnered with local hospitals and schools to beta test the technology and plans to submit it for approval from the U.S. Food and Drug Administration later this year.

3Oe plans to begin hiring for the new jobs later this year. The company says the positions will to come with salaries above the state average wage.

“Thanks to innovative life sciences companies like 3Oe, Indiana ranks as one of the five most concentrated life sciences states in the U.S., contributing $77 billion to our state’s economy,” said Indiana Secretary of Commerce Jim Schellinger. “We’re excited 3Oe is developing its game-changing product here, while simultaneously investing in Indiana’s workforce and creating good jobs for Hoosiers.”

The IEDC has offered 3Oe Scientific up to $600,000 in conditional tax credits, which the company will not be eligible to claim until Hoosier workers are hired for the new jobs. 

May 29, 2020

Medical Device Company Growing in Kosciusko County

Inside Indiana Business

WARSAW – A Warsaw-based orthopedic product development company has announced plans to expand operations. Nextremity Solutions Inc. says it will invest more than $4.5 million to transform a shell building at the Warsaw Technology Park into its headquarters and create up to 111 jobs by the end of 2024. The Indiana Economic Development Corp. says the building will allow the company to consolidate its product development and manufacturing operations under one roof.

Nextremity Solutions is partnering on the project with West Hill Development, which originally developed the shell building.

“This is such an exciting time for our team at Nextremity Solutions as we expand our capabilities to create, manufacture and deliver innovative solutions to our strategic alliance partners and to other orthopedic companies,” Rod Mayer, chief executive officer of Nextremity Solutions, said in a news release. “The shell building provides the ideal location for us as we create a synergistic partnership with Lakeland Technology going forward.”

Construction is expected to be complete by April 2021 and the company plans to begin moving employees to the new facility before the end of this year. Nextremity Solutions currently employs 24 workers and says it will begin hiring for development and manufacturing positions as needs arise.

The expansion comes two months after Nextremity Solutions acquired Lakeland Technology Inc., a contract manufacturer for the medical device industry also located in Warsaw. Financial terms of the deal were not disclosed.

The IEDC has offered Nextremity Solutions up to $1.6 million in conditional tax credits and up to $100,000 in training grants, which the company will not be eligible to claim until Hoosier workers are hired for the new jobs. The Warsaw Redevelopment Commission and the Warsaw Common Council will consider additional incentives.

May 22, 2020

Indiana Advances to Stage 3 in Back on Track Indiana Plan

On Wednesday, Governor Holcomb announced that Indiana has earned the ability to move forward to stage 3 of the Back on Track Indiana plan, two days earlier than previously planned.

Cass, Lake, and Marion counties, which were hit hardest by the coronavirus, will be eligible to enter stage 3 on June 1.

Social Gatherings

Starting Sunday (May 24), social gatherings up to 100 people may take place following the CDC social distancing guidelines. Gyms and movie theaters are opening at limited capacity and playgrounds, sports fields and sports and community pools may open.  


Restaurant’s dining rooms will continue to operate at 50% capacity in Stage 3. In Stage 4, they can move up to 75% capacity, which is scheduled to begin June 14. 


Retail, currently operating at 50% capacity, can move up to 75% capacity in Stage 3. 


If not already operating, manufacturers can open but must meet IOSHA and CDC guidelines, make provisions to maintain social distancing, and consult industry best practices.

What Limitations Will Remain?

  • Hoosiers 65 and older and those with known high-risk medical conditions should limit exposure at work and in their communities.
  • Continue remote work when possible.
  • Face coverings are recommended.
  • Nursing homes remain closed to visitors; nursing home guidance will continue to be evaluated. 

For more information on the Back on Track Indiana plan click here.

May 15, 2020

Iotron Industries Breaks Ground to Continue Worldwide Sterilization Efforts

Whitley County EDC

COLUMBIA CITY, Ind. (May 13, 2020) ­­­– Iotron Industries, a global leader in radiation processing, broke ground on their expansion project during a time when sterilization is a key priority. The expansion will add 34,000 sq. ft. to facilitate another line of sterilization capability.

“Over the last few years, due to increased market demand in the U.S. and Canada, our Indiana facility has grown to full capacity,” said Aaron Starkey, Iotron’s Vice President of U.S. Operations and Head of Business Development. “The current global pandemic has further bolstered the need to increase the supply for reliable, high scale and domestically available irradiation services.”

Construction for the expansion began earlier today with a groundbreaking ceremony led by The Hagerman Group.

“We are honored to once again handle Iotron’s construction needs in the U.S.,” said Hagerman Executive Vice President Brad Smith. “Year over year, most of our projects are with existing clients, which demonstrates the relationships and trust we build and maintain with our clients. We congratulate Iotron on this expansion project, as together we build a better future.”

Iotron Industries currently operates in a 54,000 sq. ft. facility in Park 30 and provides sterilization, bio-reduction and material modification services for the orthopedic, medical device and agricultural industries. The existing site houses Iotron’s IMPELA® brand electron-beam accelerator system, which uses no radioactive materials and is powered by standard commercial electricity.

“Whitley County is fortunate to have this unique company as a part of our diverse economy,” said Dale Buuck, Whitley County EDC president.  “On behalf of our business community, I want to congratulate the Iotron team on their past success and I’m excited to see where the future leads them.”

At the request of the Whitley County Economic Development Corporation (EDC), the Whitley County Redevelopment Commission (RDC) approved financing for Iotron’s expansion project through a bond agreement.

“The bond was a great way to incentivize Iotron’s expansion to save the company interest costs and use funds already generated by the Tax Increment Finance (TIF) district to continually improve economic development in the county,” said Jim Argerbright, Whitley County RDC president. “The use of the bond shows our flexibility as a county and alleviates the use of a tax abatement for taxpayers.”

Iotron Industries expanded its operations to the United States and Whitley County in 2011 and chose to expand in Columbia City due to the proximity to local orthopedic, medical and agriscience industries, along with being ideally situated for coast-to-coast logistics and distribution.

“With this expansion, we will create 30 to 40 new jobs during the next three years,” added Jeff Blakely, Iotron’s Corporate Vice President of Organizational Development.  “This is just the next chapter in Iotron’s 30-year history,” Blakely continued.  “Our plan moving forward is to continuously innovate, add to our already superb skill sets, position our employees for success and scale our business to meet the needs of our customers. We are extremely proud to have reached this milestone, thanks to the continued dedication of our people, our strong customer partnerships and the unwavering support from Whitley County and the State of Indiana.”

The Iotron expansion is scheduled to be completed this year.

# # #

May 11, 2020

FDA Authorizes At-Home Collection for Rutgers’ Saliva-based COVID-19 Test

Medical Device and Diagnostics Industry (MD+DI) – Amanda Pedersen

FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of using home-collected saliva samples. The test remains prescription only.

To be clear, this isn’t the first test the agency has authorized with a home-collection option, but it is the first saliva-based COVID-19 test with a home-collection option. Rutgers’ test previously had been added to FDA’s high-complexity molecular-based LDT “umbrella” emergency use authorization to permit testing of samples self-collected by patients at home using the Spectrum Solutions SDNA-1000 saliva collection device.

Last month FDA authorized the first diagnostic test with a home-collection option, but that test uses a sample collected from the patient’s nose with a nasal swab and saline. That authorization is for LabCorp’s COVID-19 RT-PCR test using samples patients collect themselves with LabCorp’s Pixel home collection kit.

“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” said FDA Commissioner Stephen Hahn, MD. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”

For more information about FDA-authorized COVID-19 tests and policies, check out these frequently-asked regulatory questions on the subject.

May 6, 2020

COVID-19 Resources

To safely open Indiana’s economy and remain vigilant about protecting our health and well-being, Governor Holcomb has laid out a road map to get Indiana back on track.

5 Stages to get Indiana Manufacturing Back on Track

Stage 1: Essential Employees Only (March 24 – May 3)

Stage 2: Open with Restrictions (May 4 – 23)

  • Manufacturers that have not been in operation may open following OSHA and CDC guidelines.
  • Screen employees daily; utilize face coverings according to best practices guidelines
  • Make provisions to maintain social distancing
  • Consult industry best practices
  • Provide employees, customers w/ your COVID-19 policies

Stage 3: Fully Open with Social Distancing (May 24 – June 13)

  • Open, must meet OSHA and CDC guidelines

Stage 4: Fully Open with Social Distancing (June 14 – July 3)

  • Open, must meet OSHA and CDC guidelines
  • Screen employees daily; utilize face coverings according to best practices guidelines
  • Make provisions to maintain social distancing
  • Consult industry best practices
  • Provide safety plans

Stage 5: Fully Open with Social Distancing (July 4 – Beyond)

  • Open, must meet OSHA and CDC guidelines
  • Screen employees daily
  • Provisions for employees to maintain social distancing
  • Consult industry best practices
  • Provide safety plans

More information about the Back On Track Indiana plan can be found at .

May 4, 2020

Roche Wins U.S. Nod for COVID-19 Antibody Test, Aims to Boost Output


(Reuters) – Roche (ROG.S) has won emergency approval from the U.S. Food and Drug Administration (FDA) for an antibody test to determine whether people have ever been infected with the coronavirus, the Swiss drugmaker said on Sunday.

Thomas Schinecker, Roche’s head of diagnostics, said the company aims to more than double production of tests from about 50 million a month to significantly more than 100 million a month by the end of the year.

Governments, businesses and individuals are seeking such blood tests to learn who may have had the disease, who may have some immunity and to potentially craft strategies to help end national lockdowns.

Basel-based Roche, which also makes molecular tests to identify active COVID-19 infections, said its antibody test has a specificity rate exceeding 99.8% and sensitivity of 100%, meaning tests would show very few false positives and no false negatives.

A false-positive result could lead to the mistaken conclusion that someone has immunity. Roche said its test relies on intravenous blood draws, with higher accuracy than finger-prick tests.

“If you take blood from a finger prick, you will never be able to achieve the same level of specificity that you will achieve … when you take blood from the vein,” Schinecker said.

“You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.”


Similar antibody tests have also been developed by companies including U.S.-based Abbott Laboratories (ABT.N), Becton Dickinson (BDX.N) and Italy’s DiaSorin (DIAS.MI).

Abbott has said the specificity and sensitivity of its test are 99.5% and 100% respectively. Diasorin has said its Liason XL test has 97.4% sensitivity and 98.5% specificity.

As demand escalates for antibody tests, an array of distributors with no background or established testing competency have also joined the experienced companies in an all-but-unregulated marketplace in the United States, according to a Reuters investigation.

Roche did not disclose a price for its test but said that it would be identical worldwide.

Schinecker foresees a high need for testing healthcare workers and their families for exposure, and those who showed signs and symptoms, to see if they have antibodies.

While antibodies typically confer some immunity, Schinecker acknowledged that much remains to be learned about the novel coronavirus before drawing definitive conclusions.

“Since this virus is not well known, one can hypothesise, but the proof will take longer,” he said. “Testing these people … is key to seeing whether or not people really have developed immunity.”

Read Reuters’ story here:

April 30, 2020

Aria Diagnostics Launches Self-Pay COVID Testing

Inside Indiana Business

CARMEL – Carmel-based Aria Diagnostics has launched an online portal for people wishing to be tested for COVID-19. The company says the self-pay portal gives users the ability to request a test online and set up a date and time for them to visit the drive-through testing site at the Aria lab on the northwest side of Indianapolis.

Aria says its staff will perform the test while the patient remains in the car. Results will be sent via email within 48 hours.

“We are extremely excited to roll out our new self-pay, drive thru testing because we truly believe that people are seeking the peace of mind that they aren’t carrying the corona virus that causes COVID-19,” said Zak Khan, co-founder of Aria Diagnostic Laboratories. “It is our driving mission and belief that, in order to beat this virus, we must test everyone. To do this, the tests must be affordable, accessible and accurate. I applaud all of the efforts being made by the federal, state and local governments to make testing a priority and hope our efforts will enhance those being rolled out daily.”

The self-pay service will cost $175 per test, according to the web portal.

Aria Diagnostics already provides testing for front line city employees in various Indiana communities, a service that began at the beginning of April in Carmel. Two weeks ago, the company announced it is partnering to provide thousands of testing kits to New York City.

After launching the web portal Wednesday morning, Khan says the company is already seeking quick results.

You can find more information on the service by clicking here.

Read Inside Indiana Business’ story here:

April 29, 2020

Abbott Labs Has Shipped One Million Rapid Coronavirus Tests To All 50 U.S. States


In less than a month, Abbott Laboratories has shipped more than one million of its highly touted “rapid” molecular tests for the Coronavirus strain COVID-19 to all 50 U.S. states.

The milestone is significant because it has been hailed in the ability of states across the U.S. to ramp up testing and surpass daily goals to re-opening their economies. In Illinois, for example, Gov. J.B. Pritzker Friday reported the state’s biggest volume of COVID-19 test results thus far, calling it a “very important milestone” in the battle against the virus.

The effort to get the ID NOW COVID-19 test to doctor’s offices, urgent care centers and temporary testing sites like drive-thru parking lot locations is a snapshot into the massive diagnostic effort under way in the U.S. Abbott’s ID NOW COVID-19 test can deliver “positive results in as little as five minutes and negative results in 13 minutes.”

“We have shipped more than 1 million of our rapid ID NOW tests to all 50 states, Washington DC, Puerto Rico and the Pacific Islands,” Abbott said in an update posted Friday on the company’s website. “The majority of these tests have been sent to outbreak hotspots and we’ve asked that customers prioritize frontline health care workers and first responders.”

The test, hailed by the White House and praised by commercial companies like drugstore chains CVS Health and Walgreens Boots Alliance, was granted the U.S Food and Drug Administration’s “emergency use authorization” less than a month ago amid a growing number of agency approvals for more rapid molecular “point-of-care” diagnostic tests that can be used in temporary screening locations, doctor’s office labs and nursing homes to detect the Coronavirus strain COVID-19 within a half hour.

The FDA has escalated approvals of rapid “point-of-care” diagnostics made by other companies including Mesa Biotech and Cepheid which are also ramping up production to meet unprecedented demand.

Earlier this week, The Advanced Medical Technology Association (AdvaMed)  projected that the medtech industry will have produced more than 25 million tests by the end of April that are largely molecular testing for the live virus. AdvaMed didn’t disclose specific company names or tallies produced by certain makers.

That kind of production will be welcome to U.S. healthcare providers on the frontlines as well as a Trump White House and federal health agencies dogged by criticism for the lack of testing for Coronavirus. 

The U.S. is considered well behind other countries when it comes to the availability of testing. As of Saturday morning, the number of U.S. Coronavirus cases was set to eclipse 930,000 as the number of deaths hurtled past 50,000.

“We’re currently manufacturing 50,000 tests per day, plan to increase ID NOW manufacturing capacity to 2 million tests a month by June and are working to expand beyond that,” Abbott disclosed.

Read Forbes’ story here:

April 27, 2020

Logansport Manufacturer Gets Early Jump on Producing PPE

Kokomo Tribune

LOGANSPORT — A local manufacturer was ahead of the game when he conceived the idea of producing protective masks and face shields for those who need them during the coronavirus pandemic.

John Hopper is the owner of Hopper Development Incorporated (HDI), which was founded by Hopper’s father Robert in 1970. HDI makes products using precision plastic injection molding and offers mold building and tooling services. Hopper said over the years the company has produced many molds and tooling for different types of plastic components, though never before for any medical device.

According to Hopper, he had an eye on the COVID-19 outbreak a few months ago when the virus was really beginning to escalate in China.

“I guess I watch a lot of news,” Hopper said. “We’re paying attention to what’s going on in the world.”

Hopper recalled that in January people around the world were getting pretty concerned about the virus. He then noticed manufacturers in other parts of the world coming out with designs for various protective gear or PPE.

“There were designs for the face shields and even the respirator masks,” he said. “It was because there was a shortage and people were getting very, very nervous. And I thought well, there’s nothing stopping that virus from hitting the United States. It just made sense.”

Hopper said he examined some of the designs for the face shields and got his team at HDI together in late February to begin the process of creating a mask using their 3D printers. It was an endeavor that took several phases.

“We have four 3D printers,” he said. “We went through about a hard week of development on these face shields. We didn’t like any of the designs that were coming out of different sources.”

According to Hopper, many of the existing designs he and his team looked at used elastic, and they had heard from healthcare workers that the elastic was uncomfortable. They also noticed elastic was almost completely unavailable to order.

“We started to experiment with a design that is kind of like a heavy duty pair of sunglasses,” Hopper said. It was a tough week of design and print. We had all of our printers running constantly, making these things.”

Hopper said a 3D printer is not a fast machine and it took about three hours to make one frame, even though there were four machines running. Hopper then made a decision. He asked the design and tooling department to make a plastic injection mold.

“They were excited about it,” he said. “They jumped on it and built a mold in a week for these that would normally take six to eight weeks to build.”

Hopper noted that throughout the design and production process, he had some valuable feedback from a friend.

“There’s a friend of mine that’s a doctor at Logansport Memorial Hospital and he offered a couple suggestions and we made those changes immediately,” Hopper said.

When the details of the design and the production process were fleshed out, the team at HDI began producing the PPE in earnest. Hopper said he brought a laser cutting machine home to his personal workshop so he could work on cutting the clear face shield itself. He has been working every day and said his family has been helping.

“My wife gave me our dining room table so I’ve got that to use as a work space as well. So it’s worked out wonderfully you know. It’s kept us busy here at home,” Hopper said.

It seems like busy is somewhat of an understatement. Hopper noted that they have been continuously sending out shipments for weeks now.

“We’ve been making daily shipments to many medical providers,” he said. “Lately the majority have been going to Logansport Memorial Hospital and our health department. We’ve sent them to Fort Wayne. We have a constant stream going to north Indianapolis.”

Hopper also said they have been sending shields to dentists, nursing homes, and eye doctors.

Incredibly, Hopper is giving the PPE away free of charge.

“We’re not selling these,” he said. “We’re donating these to any medical provider out there who wants to feel a little safer.”

He said they are getting good feedback at HDI from providers who have been using the masks. One prominent doctor at the hospital told Hopper the mask fits better than anything else he has tried, Hopper said.

While the enthusiastic response has kept Hopper quite busy at home, he is happy to do it.

“It’s a joy knowing that our healthcare providers feel protected,” Hopper said. “It’s a tiny little thing. They have so much workload, and if it makes them feel a little bit more comfortable it is so worth it. Whatever little we can do. We have the capability to make these things, so we’re doing it.”

For information on ordering protective masks from HDI, can call their office at 574-753-6621.

Read the original story here: .

April 24, 2020

Gov. Holcomb Signs Executive Order Permitting Elective Medical Procedures

INDIANAPOLIS — Governor Eric J. Holcomb today signed Executive Order 20-23 to allow health care providers and facilities to resume elective medical procedures provided they have sufficient quantities of Personal Protective Equipment (PPE) and consult the best practices and recommendations developed by their medical associations or industries.

Providers include hospital, veterinarians, dentists and others listed in Executive Order 20-22.

Click here to see the executive order:

Click here to download public service announcements (PSAs) recorded by the state for your use:

More information may be found at the ISDH website at and the CDC website at


April 21, 2020

Indy Medical Mask Producer Responds to Pandemic

Inside Indiana Business

INDIANAPOLIS – A company on the west side of Indianapolis has ramped up production exponentially, serving customers around the world, in the battle against COVID-19. Pulmodyne Inc., which manufactures airway and respiratory medical devices such as masks used in conjunction with ventilators, says it is expanding into an adjacent 7,000-square-foot building, where pre-assembly work will take place.

The company also recently hired 25 temporary workers, bringing its staff to 120 people, and plans to add 50 more production employees to keep up with demand.

“Our devices are designed to avoid intubation,” says Andy Shurig, executive director of Pulmodyne.

The company ships products around the globe and saw the rapid spread of the coronavirus even before it hit the U.S. and Indiana.

“The last week of February, we saw a big spike coming from Europe, especially Italy,” says Shurig.

Once the disease hit the U.S., demand for its medical masks exploded. “We’ve seen a massive spike in sales,” says Shurig. “Our business is up 600%.”

The flu season is typically the company’s busiest time of the year. The pandemic has pushed demand for the products dramatically higher.

“In a month, we’ve doubled our output. And I’m trying to do that again in the space of another month,” says Fred Boyer, production manager for Pulmodyne.

Boyer says the company is familiar with market fluxes, but this level is unprecedented as Pulmodyne is shipping 100,000 products a month.

“We’re continuing to get very large orders today,” says Boyer. “Everyone needs it right now. The desperation is out there.”

A big factor for Pulmodyne is the supply chain. It depends on 50-70 vendors for a variety of parts to produce its masks.

“We got some great vendors and God bless them,” preached Boyer. “When this started to unfold, we didn’t know what would be considered essential.”

Pulmodyne questioned whether its suppliers from other states would be classified that way.

“We didn’t know if a company that sold “O-rings” rings would be essential. They’re essential to us,” says Boyer. “Polybags and boxes, they matter just as much as every piece of the part we’re building.”

Shurig says he’s heard from companies that Pulmodyne had previously never done business.

“Even though our volumes are out of control, sales are out of control, but we probably turned down $10 million worth of business,” says Shurig. “As much as Fred is doing a herculean effort, doubling and doubling again, we’re nowhere close to keeping up with demand.”

Boyer says the company is operating 24 hours a day. He said initially it was doing voluntary overtime. But now it’s necessary.

The veteran production manager says workers who are assembling the units are under pressure to fill orders, but they seem to understand the mission.

“Everybody what needs to be done, our role in this, how important we are. It gives us a great sense of purpose,” says Boyer. “I’ve been doing this a long, long time. And I don’t know that I if ever been more stressed, and yet more purposeful than I do right now.”

Boyer says even when the pandemic begins to wane, he expects demand will continue as governments stockpile their products for future outbreaks. For workers, that means jobs, once considered temporary, may turn into full-time positions.  

“We have orders in house to last until the end of the year,” says Boyer. “That’s been our crisis; trying to get it out quick enough.”

Read the Inside Indiana Business story here: .

April 20, 2020

Roche Develops New Serology Test to Detect COVID-19 Antibodies

Roche Diagnostics
  • The new Elecsys Anti-SARS-CoV-2 serology test can support the detection of antibodies against SARS-CoV-2 in patients who have been exposed to the virus which causes COVID-19
  • The detection of these antibodies could help indicate if a person has gained immunity against the virus and inform treatment decisions
  • Roche aims to have this test available by early May, in countries accepting the CE mark1 and is actively working with the US Food and Drug Administration for an Emergency Use Authorisation2

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the development and upcoming launch of its Elecsys® Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes the COVID-19 disease.

Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms.³ Additionally, the test can support priority screening of high risk groups, such as healthcare workers, food supply workers who might already have developed a certain level of immunity and can continue serving and/or return to work. Once we understand more about the immunity of COVID-19, it could also help society return faster to normality.

Severin Schwan, CEO Roche Group: “Following the launch of our high-volume PCR test in mid-March to detect active infection of the disease, we are now going to launch a new antibody test in early May. Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic. Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally.”

“Roche is deeply committed to supporting the global response to the COVID-19 pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”

The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, using human serum and plasma drawn from a blood sample, to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The test may be used in epidemiological research to help better understand the spread of the disease and may also be used together with molecular tests to aid in the diagnosis of suspected COVID-19 patients. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available in laboratories around the world.

Roche aims to have the antibody test available by early May in countries accepting the CE mark and is actively working with the FDA for an Emergency Use Authorisation. Roche is planning on an accelerated ramp up of monthly production to high double-digit million tests by June and will further scale up production as fast as possible.

About SARS-CoV-2 (coronavirus)
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.

Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.

To control the spread of the infection, the World Health Organisation (WHO) recommends regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs and avoiding close contact with anyone showing symptoms of respiratory illness.

About Elecsys Anti-SARS-CoV-2 serology test
Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in vitro detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.⁴

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

All trademarks used or mentioned in this release are protected by law.

[1] CE-IVD marking is granted  through completion of a comprehensive technical validation and self declaration under the European Directive for In Vitro Diagnostic Medical Devices.
[2] The Emergency Use Authorisation (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of medical countermeasures needed during public health emergencies
[3] Thus, 29 of the 33 patients who were positive for SARS-CoV-2 at admission (87.9%) had no symptoms of Covid-19 at presentation –
[4] Full specifications of the Roche immunoassay systems, including throughput, can be found on our diagnostics.roche website

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: [email protected]
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April 1, 2020

How to Help: COVID-19 Resources

As you can imagine, the Trump Administration has received a deluge of offers from the private and non-profit sectors to provide or produce PPE, ventilators, and other critical supplies in response to COVID-19. As a result, HHS has established a centralized platform for receiving and vetting these requests. If you or your office are interested in helping the effort to combat the spread of COVID-19, FEMA has established a website ( providing more information. Examples for the private sector include:

  • To sell medical supplies or equipment to the federal government, please submit a price quote under the COVID-19 PPE and Medical Supplies Request for Quotation. Full details can be found in the solicitation (Notice ID 70FA2020R00000011)
    • This solicitation requires registration with the System for Award Management (SAM) in order to be considered for award, pursuant to applicable regulations and guidelines. Registration information can be found at Registration must be “ACTIVE” at the time of award.
  • If you have medical supplies or equipment to donate, please provide us details on what you are offering.
  • If you are a private company that wants to produce a product related to the COVID response – email [email protected].
  • If you are a hospital or healthcare provider in need of medical supplies, please contact your state, local, tribal or territory department of public health and/or emergency management agency.
  • To sell medical supplies or equipment to the federal government, please submit a price quote under the COVID-19 PPE and Medical Supplies Request for Quotation. Full details can be found in the solicitation (Notice ID 70FA2020R00000011)
    • This solicitation requires registration with the System for Award Management (SAM) in order to be considered for award, pursuant to applicable regulations and guidelines. Registration information can be found at Registration must be “ACTIVE” at the time of award.
  • If you have medical supplies or equipment to donate, please provide us details on what you are offering.
  • If you are a private company that wants to produce a product related to the COVID response – email [email protected].
  • If you are a hospital or healthcare provider in need of medical supplies, please contact your state, local, tribal or territory department of public health and/or emergency management agency.
  • If you are interested in doing business with FEMA and supporting the response to COVID- 19 with your company’s non-medical goods and/or services, please submit your inquiry to the Department of Homeland Security (DHS) Procurement Action Innovative Response Team (PAIR) team at [email protected].

For additional information please visit FEMA’s website:  

March 26, 2020


Dear Members of Indiana’s Medical Device Industry:
Our front line health care providers are running dangerously low on equipment they desperately need in their battle with the COVID 19 virus.
Much of the immediate need centers around:

  • isolation gowns
  • face masks and shields
  • gloves
  • specimen collection devices (swabs)
  • specimen transport packages
  • hand sanitizer
  • surface disinfectant
  • ventilators

If you have access to any of these supplies, have the capacity in your companies to produce them or know somebody that does, please let us know ASAP and we will connect you to folks who can get these supplies to our health care providers that are most in need immediately.  
Thank you for your help during these unprecedented times.


April 12, 2019

IMDMC welcomes representatives from Sichuan

This morning, representatives from IMDMC, Cook Regentec and the Indiana Economic Development Corporation, among others, welcomed members of the China Council for the Promotion of International Trade – Sichuan Council during their inaugural visit to Indiana.   

The discussion centered around Indiana’s position as a global leader in medical device manufacturing – citing robust manufacturing capabilities, university and workforce excellence, world-class global transportation access and a dynamic entrepreneurial ecosystem as leading factors in the industry’s success in our state.

We look forward to the future opportunities and discussions this meeting will provide.

January 23, 2018

IMDMC commends Indiana delegation, congressional leaders for vote suspending the medical device tax

INDIANAPOLIS – The Indiana Medical Device Manufacturers Council (IMDMC) commends lawmakers on suspending the job-killing medical device excise tax for two years. This action by Congress was part of the continuing resolution to end the government shutdown.

“The IMDMC applauds the Indiana delegation and congressional leadership for their hard work to suspend the medical device tax for two more years. The action made by lawmakers to suspend this tax allows the medical device industry to continue to invest in innovative medical technology and job growth,” said Anne Hathaway, IMDMC Executive Director. “This job-saving, tax suspension especially benefits Hoosiers because Indiana is a leader in the medical device industry as well as being home to the medical device capital of the world in Warsaw, Ind.

“This suspension is a step in the right direction and we look forward to working with policymakers over the next two years to get the tax fully repealed. A full repeal of the tax is crucial for the continuation of research and development of new products that can save and improve the lives of Hoosiers, Americans and people worldwide.”

Indiana is a leader in the medical device industry and employs more than 20,000 Hoosiers. Jobs within the medical device industry pay 41.7 percent more than the average wage in Indiana.
IMDMC is an association of medical device manufacturers and other associated companies, formed in 1991, to promote the medical device industry. By uniting Indiana medical device manufacturers, large and small, IMDMC serves to amplify the voices and convey the interests of these innovative companies before state and federal legislatures and regulatory agencies. IMDMC also offers education and training opportunities to its members as a way to network and continue to evolve with the ever-changing industry.

November 1, 2017

Change in leadership at IMDMC

INDIANAPOLIS (Nov. 1, 2017) – The Indiana Medical Device Manufacturers Council announced today that Anne Hathaway of Hathaway Strategies, will become the new executive director for IMDMC.

Kathy Heuer, former IMDMC Executive Director, announced to the board of directors in May that she would be retiring this year, and the search for new leadership then ensued. Hathaway was introduced today to IMDMC members at their annual conference.

“Anne will be a tremendous addition to our association. I am pleased to see someone who is so devoted to Indiana and our industry lead IMDMC through the next phase of our growth,” Heuer said. “IMDMC completed our new Strategic Plan a year ago, and under Anne’s leadership I believe we will be well-situated to see continued growth for both our membership and our activities.”

Tom Barnett, National Director of State Government Affairs at Roche Diagnostic, and current President of the Board of Directors for IMDMC, added “I want to thank Kathy for her leadership and dedication to IMDMC for the past three years. In the midst of this transition, I know the board is looking forward to working with Anne, as she brings fresh ideas to the table. Our members are our number one priority and with her help, we will continue to strive to provide the best in cutting-edge education within the medical device industry, along with ensuring that our members voices are heard at the local, state and national levels.”

Hathaway, a native of Illinois, has a vast background in political campaigns, association management, consulting and fundraising. She has been recognized for her innovative leadership skills while serving as the chief of staff for the Republican National Committee. Hathaway started her Indianapolis-based business, Hathaway Strategies, in 2009 and currently sits on multiple boards, including the Indiana Chamber of Commerce, the Indianapolis Chamber of Commerce and is the chair of The Julian Center Board.

“I’m honored to have the opportunity to be a part of the Indiana Medical Device Manufacturers Council,” Hathaway said. “I look forward to implementing the newly completed Strategic Plan, and promoting an industry that has a major impact on our state.”